MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM

Model Number	DL-344-3.5-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The explanted leads were not returned to neuropace for analysis.However, review of the device ecog and lead impedances confirmed that the ecog data are suggestive of a potential lead break in both leads.
Event or Problem Description
A review of the patient's ecog data indicated signal artifact on the left depth lead (port 1) starting on (b)(6) 2018, suggestive of a possible lead break.The patient was scheduled for a routine rns neurostimulator replacement and replacement of the lead in (b)(6) 2019.Subsequently, the patient's right depth lead connected to port 2, demonstrated similar issues starting on (b)(6) 2019.No information regarding seizure-related trauma or other potential causal factors resulting in the lead breaks were provided by the treating center.During the surgical procedure on (b)(6) 2019, both leads were removed and two new depth leads were implanted and connected to the rns neurostimulator without complication.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 8498193
• Report Number: 3004426659-2019-00012
• Device Sequence Number: 2675586
• Product Code: PFN
• UDI-Device Identifier: 00855547005021
• UDI-Public: 010085554700502117191214
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: DL-344-3.5-K
• Device Catalogue Number: 1007606
• Device Lot Number: 23112-1-1-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR